The aim of this study is to test whether Traditional Chinese Medicines (TCMs) are effective and safe for treating COVID-19 infection. After the enrolment of approximately 30 subjects, the recruitment will be paused, and planned interim analysis will be performed to preliminarily investigate the efficacy and safety of TCMs in patients infected with COVID-19.
In December 2019, a cluster of patients with pneumonia in Wuhan, China, was caused by a novel
betacoronavirus, which named the 2019 novel coronavirus (COVID-19). It was frequently
reported that COVID-19 could be a public health crisis with high infectiousness, and it
naturally spread across the country. Most of patients with COVID-19 infection were found to
have non-specific symptoms including fever, cough, myalgia and fatigue. In addition, some
patients were more likely to develop severe respiratory illness similar to severe acute
respiratory syndrome (SARS), or even die. However, there was no timely and effective
treatment of patients with COVID-19 infection. Traditional Chinese medicines (TCMs), are
derived from plants and usually incorporate one or more herbs as the basic drug(s) to treat
the disease. An RCT was performed to investigate TCM was effective and safe for treating
COVID-19 infection. Eligible subjects will be randomized in a 1:1 ratio, and 1 subject on
conventional medicines and TCMs granules for every 1 subject on conventional medicines.
According to recommendations for prevention and control of pneumonia cause by COVID-19
infection from China National Health Commission, conventional medicines involve oxygen
therapy and antiviral therapy (alfa interferon via aerosol inhalation, and
lopinavir/ritonavir, p.o). Additionally, planned interim analysis will be performed, because
the prevention and control of COVID-19 infection might affect estimated enrollment.
Drug: Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) and Traditional Chinese Medicines (TCMs) granules
Conventional medicines: oxygen therapy, antiviral therapy (alfa interferon via aerosol inhalation, and lopinavir/ritonavir, 400mg/100mg, p.o, bid) for 14 days.
Traditional Chinese Medicines (TCMs) granules: 20g, p.o, bid, for 14 days.
Drug: Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir)
Conventional medicines: oxygen therapy, antiviral therapy (alfa interferon via aerosol inhalation, and lopinavir/ritonavir, 400mg/100mg, p.o, bid) for 14 days.
Inclusion Criteria:
- Confirmed COVID-19 infection case in term of laboratory evidence;
- 80 years ≥ age ≥ 14years;
- Within 72 hours after the onset of abnormalities shown by Chest radiology or several
symptoms (fever and cough).
Exclusion Criteria:
- Age < 14 years or > 80 years;
- Pregnant or lactating female;
- One of the following items occurred at the enrollment: (i) respiratory failure
necessitating mechanical ventilation; (ii) liver failure: total bilirubin ≥ 10mg/dL
and/or severe coagulation disorders; (iii) renal function failure: although adequate
circulating blood and cardiac output, urine ≤ 0.5ml/kg·h, Cr or BUN ≥ 1.5 times normal
elevation;
- Intake of Chinese medicinal herbs during the past 2 weeks;
- Refused to sign an informed consent form prior to study participation;
- Unwilling and unable to comply with protocol request.
The Fifth Medical Center, General Hospital of PLA
Beijing, Beijing, China
Investigator: Rui-lin Wang, Dr.
Contact: +86 66933323
wrl7905@163.com
Rui-lin Wang, Dr.
+86 10 66933436
wrl7905@163.com
Jia-bo Wang, PD.
+86 10 66933323
pharm_sci@126.com
Xiao-he Xiao, PD., Study Director
302 Military Hospital